The purpose of this study is to determine whether Icotinib is at least non-inferior to Gefitinib in the treatment of advanced non-small cell lung cancer (NSCLC) patients after one or two chemotherapies.

Safety and Tolerability [ Time Frame: Assessed over two years ] [ Designated as safety issue: Yes ]

Adverse Events (AEs) and Serious AEs (SAEs) are presented regardless of causality for patients who received at least one dose of Icotinib or Gefitinib. Events were graded by the investigator using the NCI CTCAE Scale (version 3.0) which provides a grading scale for each AE term.

Lung cancer is the rapidest increased type of cancer in China with over 5 times incidence rate increase during the past 30 years . It is the leading cause of death of cancer in man and 2nd in women. With the development of gefitinib and erlotinib, EGFR-TKI (epidermal growth factor receptor -tyrosine kinase inhibitor) is the most successful novel drugs developed for the treatment of these patients in recent years, especially for NSCLC patients in Asia including China. Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. It appears to be at least as good as gefitinib in terms of efficacy and better in terms of safety in phase I/II trials. In this study, a randomized, double-blind, gefitinib as control, multi-center phase III trial was designed to evaluate the safety and efficacy of icotinib in the treatment of advanced NSCLC patients after failure of 1 or 2 chemotherapy. PFS (progress free survival) is the primary end-point with OS (overall survival), ORR (objective response), TTP (time to progress), HRQOL and safety as the secondary end-point. A total of 400 patients will be recruited. EGFR and K-ras gene mutational analysis as well as a population PK study have also been proposed.

Eligibility

Ages Eligible for Study:

18 Years to 75 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Confirmed NSCLC with Histology or cytology; advanced （IIIb/IV).

Must have received 1 or 2 chemotherapy (at least 1 is platin based)before, and prior chemotherapy must be completed at least 4 weeks before study enrollment; =.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01040780

Locations

China, Beijing

307 Hospital of PLA

Beijing, Beijing, China, 100071

Beijing Chao-Yang Hospital

Beijing, Beijing, China, 100020

Beijing Chest Hospital

Beijing, Beijing, China, 101149

Bejing Cancer Hospital

Beijing, Beijing, China, 100036

Cancer Hospital, Chinese Academy of Medical Science

Beijing, Beijing, China, 100021

Chinese PLA General Hospital

Beijing, Beijing, China, 100853

Peking Union Medical College Hospital

Beijing, Beijing, China, 100032

Peking University Third Hospital

Beijing, Beijing, China, 100079

China, Chongqing

Third Affiliated Hospital, Third Military Medical University

Chongqing, Chongqing, China, 400042

China, Guangdong

Guangdong General Hospital

Guangzhou, Guangdong, China, 510080

Guanghzou General Hospital of PLA

Guangzhou, Guangdong, China, 510000

Nanfang Hospital， Southern Medical University

Guangzhou, Guangdong, China, 510515

Sun yat-sen Univerisity Cancer Center

Guanzhou, Guangdong, China, 510060

China, Hunan

Hunan Cancer Hospital

Changsha, Hunan, China, 410013

the Second Xiangya Hospital，Central South University

Changsha, Hunan, China, 410011

China, Jiangsu

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China, 210009

81 Hospital of PLA

Nanjing, Jiangsu, China, 210002

Nanjing General Hospital of Nanjing Command，PLA

Nanjing, Jiangsu, China, 210002

China, Jilin

Jilin Cancer Hospital

Changchun, Jilin, China, 130012

China, Shanghai

Changhai Hospital， Second Military Medical University

Shanghai, Shanghai, China, 200433

Ruijin Hospital，Shanghai Jiao-Tong University

Shanghai, Shanghai, China, 200023

Shanghai Pulmonary Hospital

Shanghai, Shanghai, China, 200433

Zhongshan Hospital，Fudan University

Shanghai, Shanghai, China, 200032

China, Shanxi

Xijing Hospital, Fourth Military Medical University

Xi-An, Shanxi, China, 710032

Tangdu Hospital, Fourth Military Medical University

Xi-an, Shanxi, China, 710000

China, Zhejiang

The First Affiliated Hospital of College of Medicine, Zhejiang University